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Software › 21st Century Cures Initiative

Polsinelli

FDA Guidance on Software as Medical Devices Represents Broader Deregulation Trend

Polsinelli on

The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more

Fenwick & West Life Sciences Group

Digital Health Companies May Find a Faster Path to Market Under the FDA's Digital Health Plan

Fenwick & West Life Sciences Group on

It looks like the FDA is moving forward—and swiftly—with the digital health plan articulated in FDA Commissioner Scott Gottlieb's June blog post, previously outlined in this post. Closely tracking the commissioner’s post, the...more

Morgan Lewis

The 21st Century Cures Act and Its Effect on Digital Health

Morgan Lewis on

New legislation includes a broad regulatory exemption for medical software. On December 7, the US Senate passed the 21st Century Cures Act and sent it to President Barack Obama, who has promised to sign it. This new...more

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